Quality Assurance and Regulatory Affairs Manager Restem Group Inc. / thebiobox LLC Miami, FL Job Details Full-time $73,500 - $75,000 a year 18 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Vision insurance Life insurance Qualifications Bachelor's degree Full Job Description Overview The Quality Assurance and Regulatory Affairs Manager will support Exora Skin Labs' quality systems, regulatory compliance, and operational documentation. This role is responsible for maintaining SOPs, coordinating regulatory submissions with external partners, supporting quality documentation, and ensuring compliance across manufacturing and commercialization activities. The position works closely with Operations, R D, Manufacturing, Clinical, and Marketing to support product launches and ongoing quality initiatives. The successful candidate will play a crucial role in maintaining the company's commitment to quality and safety, while also ensuring that all products meet regulatory requirements. The QA&RA Manager will have the opportunity to contribute to the overall success of a growing bio-cosmetic company.

THIS IS NOT AN IN-LABORATORY ROLE. KEY RESPONSIBILITIES

Quality Assurance Develop and implement quality management systems and processes to ensure compliance with GMP and ISO standards. Conduct internal audits to assess compliance with quality standards and identify areas for improvement. Establish processes for receiving customer feedback and recording any customer complaints. Investigate and resolve any product quality issues or adverse reactions, implementing corrective and preventive actions (CAPA) and recall procedures as necessary. Regulatory Affairs Ensure compliance with U.S. and international cosmetic regulations, including FDA, MoCRA, EU, and other applicable requirements. Review and approve product claims, marketing materials, social media content, and website language. Maintain regulatory documentation, including Product Information Files (PIFs), SDSs, specifications, Coas, and technical dossiers. Manage ingredient reviews, INCI nomenclature, and labeling compliance. Develop and maintain SOPs and quality systems related to regulatory activities. Monitor changes in regulations and communicate impacts to the organization. Serve as the primary regulatory liaison with testing laboratories, consultants, and regulatory agencies.

QUALIFICATIONS

Note:

This is NOT an all-inclusive list of responsibilities. Experience Bachelor's degree in basic science (e.g., chemistry, cell biology, molecular biology, pharmaceutical sciences) is required. A master's degree is preferred. Strong working knowledge of cosmetics regulations, including but not limited to FDA regulations (if applicable), EU cosmetics regulation, and international cosmetic regulatory frameworks. Familiarity with GMP, GDP, and ISO standards. 2+ years of work experience in regulatory affairs and quality management in the cosmetics industry. Excellent understanding of cosmetic product development, including formulation, stability, and safety assessment. Strong analytical and problem-solving skills. High standards of organization, attention to detail, efficiency, and precision. Excellent communication and interpersonal skills. Proficient in Google Suite and Adobe Acrobat Pro. Cosmetic experience is preferred. Join our team as a Quality Assurance and Regulatory Affairs Manager where you will have the opportunity to make a significant impact on our product quality while fostering a culture of excellence within the organization. We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other legally protected status. All employment decisions are based on business needs, job requirements, and individual qualifications, in accordance with applicable federal, state, and local laws.

Job Type:

Full-time Application Question(s): Please describe your prior experience in cosmetics or related industries. What is your desired salary range?

Work Location:

In person

Pay:

$73,500.00 - $75,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Health savings account Life insurance Vision insurance

Work Location:

In person